# K051963: BE-Certain Pregnancy Test

- Pathway: 510(k) (Traditional)
- Applicant: Natureplex, LLC
- Decided: Nov 23, 2005 after 127 days
- Product code: LCX (Kit, Test, Pregnancy, Hcg, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.1155
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K033658 (2004). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033658: E.P.T. Pregnancy Test, Unipath, Ltd. (2004) Summary page 2.

## Indications for use
The BE CERTAIN Pregnancy Test is intended for the qualitative identification of the elevated level of human Chorionic Gonadotropin (hCG) in urine to aid in the determination of pregnancy. It is for over-the-counter consumer use.

Source page: https://510kreport.com/device/K051963
Methodology: https://510kreport.com/methodology